Collegium Pharmaceutical Announces Successful Completion of Proof of Concept Clinical Trial for Novel Combination Allergic Rhinitis Product.

CUMBERLAND, R.I. -- Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced the results of its randomized, placebo controlled, multi-center "Proof of Concept" (POC) trial that was initiated to investigate the potential for its novel, 'once a day' combination product for the treatment of seasonal allergic rhinitis (SAR) to meet its desired endpoints. The approved commercially available components of the product candidate were used for this trial.

After meeting with the FDA and receiving guidance on the basis of approval, Collegium has established a clinical plan aimed at achieving regulatory approval for its patent protected modified release formulation (CP-118) and has designed the protocol for its Phase 3 pivotal trials. The POC trial was designed to investigate the potential of the combination product to achieve the desired endpoints in the pivotal trials.

The POC trial enrolled 76 patients in a three (3) arm, randomized, placebo controlled trial during the fall allergy season in four (4) sites in the US. The objective of the trial was to test a combination product against one of its individual components and placebo. The primary endpoint was reduction in Total Nasal Symptom Score (TNSS). The results of the trial provided sufficient evidence that Collegium's product candidate should be able to be differentiated from one of its individual active components and placebo in the reduction of the primary endpoint that was requested by the FDA. In addition, the combination product used in this trial showed an adverse event profile similar to that of the single active component alone and placebo. After the completion of an End of Phase 2 meeting with the FDA, Collegium expects to finalize its Phase 3 protocol and commence pivotal trials with its modified release formulation (CP-118) and to file a NDA after the completion of all regulatory requirements.

In the United States, allergic rhinitis affects approximately 40 million people, according to the American Academy of Allergy, Asthma, and Immunology. Annual sales of allergic rhinitis products are currently estimated at greater than $4 billion per year in the U.S. Antihistamine products comprise a significant sector of this market. Antihistamines that are currently available for the treatment of allergic rhinitis include the older antihistamines which tend to have a sedating effect, such as diphenhydramine (e.g. Benadryl[R]), and the newer antihistamines which are considered less sedating, such as loratadine (e.g. Claritin[R]).

Clinicians estimate that 20-40% of patients with allergic rhinitis have worsening symptoms at bedtime which can cause difficulties sleeping and incomplete treatment response throughout the day. Currently, there are no 'once a day' products on the market in the U.S. that capitalize on the unique benefits of both types of antihistamine in a single formulation. Collegium's patented combination product incorporates both a sedating and non-sedating antihistamine in a modified release formulation.

"Many patients with allergic rhinitis experience early morning symptoms, either experienced during the night or immediately upon awakening in the morning. Nocturnal symptoms of rhinitis are unpleasant and cause interference with sleeping, leading to significant sleep abnormalities. These symptoms are still a frequent problem in spite of our current therapeutic modalities for allergic rhinitis. Based upon my review of the data from this POC clinical trial, this unique combination product may provide a solution for these types of patients" said Dr. William Storms, a clinical professor at the University of Colorado and noted expert in the field of allergy and asthma.

"This product has the potential to address a large unmet patient need in the treatment of allergic rhinitis. A 'once a day' combination product such as CP-118 allows patients to take full advantage of the beneficial effects of a sedating antihistamine at bedtime in addition to the benefits of a non-sedating antihistamine during the course of the day." said Michael Heffernan, R.Ph., President, Collegium Pharmaceutical.

About Collegium Pharmaceutical

Collegium Pharmaceutical, Inc. is a privately held specialty pharmaceutical company focused on the development of proprietary, late stage pharmaceutical products. These products target market opportunities through product improvement and line extension strategies protected by intellectual property (IP). Collegium applies customized pharmaceutical formulations and IP strategies to active ingredients that have been shown to be safe and effective, creating a portfolio of improved pharmaceutical products with potentially less development risk and shorter times to market. Collegium uses its broad expertise in IP development, drug formulation, manufacturing, basic science (chemistry, biology, bioengineering), marketing and clinical trials management to identify and execute product opportunities for itself and its partners. For more information, visit the Company's website at www.collegiumpharma.com